September 8, 2020
What is the risk of clinical relapse after discontinuing vedolizumab?
Most patients with inflammatory bowel disease relapse within a year after vedolizumab is discontinued, despite achieving steroid-free clinical remission. Not all of those who relapsed could reattain remission by resuming therapy. Patients need to consider carefully the risk. benefits and outcomes of vedolizumab withdrawal.
Martin A, Nachury M, Peyrin-Biroulet L, et al. Maintenance of Remission Among Patients With Inflammatory Bowel Disease After Vedolizumab Discontinuation: A Multicenter Cohort Study. J Crohn’s Colit. 2020;14(7):896–903; https://academic.oup.com/ecco-jcc/article-abstract/14/7/896/5701423?redirectedFrom=fulltext
Researchers at 21 centers in France retrospectively collected data from 58 Crohn’s disease (CD) patients and 37 ulcerative colitis (UC) patients who discontinued vedolizumab after at least six months of treatment with the drug and after achieving steroid-free clinical remission for at least three months. The median duration of vedolizumab treatment was 17.5 months (range: 10.6–25.4) and most patients had previously received an anti-tumor necrosis factor (TNF) drug.
The most common reasons for treatment discontinuation included pregnancy (39%), safety concerns (28%), patient preference (25%) and financial concerns (8%). Fifty-eight percent and 73% of CD and UC patients, respectively, had achieved mucosal healing at the time of treatment discontinuation.
According to the findings, 64% of patients experienced clinical disease relapse a median 11.2 months [Range: 5.8–17.7] after vedolizumab discontinuation. The likelihood of ongoing remission at 6, 12 and 18 months was 83%, 59% and 36%, respectively. Multivariate analysis identified C-reactive protein levels <5 milligrams per liter at the time of vedolizumab discontinuation (hazard ratio [HR]: 0.56; 95% confidence interval [CI]: 0.33–0.95; p=0.03) and discontinuation of vedolizumab as a result of the patient’s choice (HR = 0.41, 95% CI: 0.21–0.80; p=0.009) as significant predictors of ongoing remission. Among the 39% of patients re-treated with vedolizumab after relapse, 71% and 62.5% experienced steroid-free clinical remission after 14 weeks and a median of 11 months (range: 5.4–13.3), respectively, of re-treatment. Relapse rates did not differ between CD and UC patients and no infusion reactions occurred.
Study Design: Retrospective observational cohort
Allocation: Not applicable
Level of Evidence: 2b (Oxford Levels of Evidence)